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Enterprise 8000x

EUDAMED

Class I (EU MDR)

Ref 8X23HN003BDABAModel 8X13GY113DCABARef 8X23WZ133BCDAARef 8X23GY103BCAZARef 8X23HL113BFACARef 8X23V4103FCAZBRef 8X23HQ113BBBOARef 8X23HQ013BBAABRef 8X23GL113FBBVBRef 8X23HR113FFDAARef 8X23OQ113BEDAARef 8X23GA003DCABARef 8X23GN113BEABARef 8X23HR113FDDAARef 8X23GC103BEABARef 8X23HR113DADAARef 8X23GC103BCBOARef 8X23GC103BAABARef 8X23HR113DBDAARef 8X23PQ133DFDSARef 8X23HP103BDABBRef 8X23GL103BDBOARef 8X23HU113DCADARef 8X23GE103BAABARef 8X23GC003BEABARef 8X23HZ113DFDAARef 8X23HN113FEABARef 8X23GG103BCBOARef 8X23HR113DEDAARef 8X23YZ113BECHARef 8X23GC103DCABARef 8X23HQ113BFACARef 8X23HQ113DEADARef 8X23OA003BBAAARef 8X23SS113BEABBRef 8X23HQ113BCAAARef 8X23O3003DFADARef 8X23VR133BFAJARef 8X23GA003BCDNARef 8X23OQ113BNDAARef 8X24HF103BFBOARef 8X23GE103BBABARef 8X23GA003BFABARef 8X23HR113FFAZARef 8X23YY133FFDABRef 8X23HQ103BFABARef 8X23TN133BFAHBRef 8X23GF113DAAAARef 8X23HR113BAACARef 8X23GQ003DCAZARef 8X23GN003BBBOARef 8X23HC103DCAAARef 8X23O3113BFDAARef 8X23V5123DCADARef 8X23OV133BCDSARef 8X23SG113BFDSARef 8X24HC003FBBOARef 8X24HZ113DFAZARef 8X23OG103DAABARef 8X23GC103BFABARef 8X23HQ133BFDSARef 8X23GY113BFAZARef 8X23HR113FADAARef 8X24HR113DEDAARef 8X23HR113DABOARef 8X23GG103DEABARef 8X23HG103DEABARef 8X23TL133BBAHARef 8X23GC003DBAAARef 8X23GL103BBBOARef 8X23GU103DEABARef 8X23YH113FFAAARef 8X23OQ113DEDAARef 8X23HR113DFADARef 8X23GM113BEDAARef 8X23GQ103BCAHBRef 8X23GQ003BFABARef 8X23GN003BCBOARef 8X23GN003BEABBRef 8X24GA003BAABBRef 8X23GN103FCAHBRef 8X23TG113BBABARef 8X23UG113BEABARef 8X23G0103BDABARef 8X23YB133FAACARef 8X23Y0113DFADARef 8X23RC013BCBOARef 8X23GQ103BBAHBRef 8X23HY103BFABARef 8X23HR133DEDSARef 8X23HQ113BBADARef 8X23HH103BBADARef 8X23HQ113BDABARef 8X23HB103BBAAARef 8X23HQ113DCDAARef 8X24OH113BDABARef 8X23TL133BEAHBRef 8X23T1033BFAJARef 8X23GL113BCAHBRef 8X23HR113BDACARef 8X24OL113FEAHBRef 8X23V5103DCADARef 8X23PL103DBABARef 8X23SZ113FFDSARef 8X23HR113FEDAARef 8X23OR113DDDAARef 8X23GE103DBAAARef 8X23HQ113BEADARef 8X23VQ133DFDSARef 8X23UR113DFDAARef 8X23GA003BBCHBRef 8X24OR113BFAHBRef 8X23GC003BBAZARef 8X23HG003DEABARef 8X23HY113BEAJARef 8X24GG103DAAAARef 8X23HD113BAAAARef 8X23OQ103FDBOARef 8X23GL113BEAHARef 8X23HN103BCABARef 8X23HL103FCBOARef 8X23HZ113DBDAARef 8X23UQ133BFABARef 8X23HY113BEBOARef 8X23HJ103DCDAARef 8X23GA003BCAZARef 8X23HZ113BDACARef 8X33TQ113BFAHBRef 8X23GJ103BBAHBRef 8X23GS103BDABBRef 8X23GC003BBABARef 8X23GC113BBAABRef 8X23HR113BBACARef 8X23PU103BFANARef 8X23WZ113BCDAARef 8X23GB103BBAAARef 8X23HY133BFAJARef 8X23GE113BABOARef 8X23GU003BCAKBRef 8X23G0003DADAARef 8X23HY113BCABARef 8X23GL103BEAHBRef 8X23YY113BFANARef 8X23GC003BCBOARef 8X23HQ103DCABARef 8X23HP103BEABBRef 8X23GM003BEAABRef 8X23HP113BAACARef 8X23HA003BCAZARef 8X23HQ113BFAJARef 8X23VG003BCAZARef 8X23GS113BEABBRef 8X23GP103BEDJBRef 8X23GC103DDABARef 8X24HJ103DCDAARef 8X23HH103BDAABRef 8X23HQ113BEACARef 8X23HQ113FCDAARef 8X23HU113FBBOARef 8X23GG113DCAAARef 8X23GG103BDABARef 8X23HP113BDACARef 8X23HG013DEABARef 8X23HR113DCDAARef 8X23GG013BDABARef 8X23GC003BCAZARef 8X23GR113BDDJBRef 8X23HZ113DADAARef 8X23HR113BEACARef 8X23HQ003DEABARef 8X23GN103BDABARef 8X23GL103BCAHARef 8X23O2113BNDAARef 8X23HL103BBAHBRef 8X23T5133BFDAARef 8X23GE103BEABARef 8X23GL003DEABARef 8X23GD113BCAAARef 8X23GL103BBAHARef 8X23GL003FBBOARef 8X23HQ103BBBOARef 8X23GN103BCABARef 8X23GS113DCDSARef 8X24GL133DEBOARef 8X23HR113DFDAARef 8X23HQ113BBACARef 8X23GQ003BABOARef 8X23HZ113DEDAARef 8X23VQ123BFAKB

by ArjoHuntleigh AB

Identity

Trade Name
ENTERPRISE 8000X EUDAMED
Device Name
ENTERPRISE 8000X EUDAMED
Model / Reference
8X13GY113DCABA EUDAMED
8X23HN003BDABA EUDAMED
8X23WZ133BCDAA EUDAMED
8X23GY103BCAZA EUDAMED
8X23HL113BFACA EUDAMED
8X23V4103FCAZB EUDAMED
8X23HQ113BBBOA EUDAMED
8X23HQ013BBAAB EUDAMED
8X23GL113FBBVB EUDAMED
8X23HR113FFDAA EUDAMED
8X23OQ113BEDAA EUDAMED
8X23GA003DCABA EUDAMED
8X23GN113BEABA EUDAMED
8X23HR113FDDAA EUDAMED
8X23GC103BEABA EUDAMED
8X23HR113DADAA EUDAMED
8X23GC103BCBOA EUDAMED
8X23GC103BAABA EUDAMED
8X23HR113DBDAA EUDAMED
8X23PQ133DFDSA EUDAMED
8X23HP103BDABB EUDAMED
8X23GL103BDBOA EUDAMED
8X23HU113DCADA EUDAMED
8X23GE103BAABA EUDAMED
8X23GC003BEABA EUDAMED
8X23HZ113DFDAA EUDAMED
8X23HN113FEABA EUDAMED
8X23GG103BCBOA EUDAMED
8X23HR113DEDAA EUDAMED
8X23YZ113BECHA EUDAMED
8X23GC103DCABA EUDAMED
8X23HQ113BFACA EUDAMED
8X23HQ113DEADA EUDAMED
8X23OA003BBAAA EUDAMED
8X23SS113BEABB EUDAMED
8X23HQ113BCAAA EUDAMED
8X23O3003DFADA EUDAMED
8X23VR133BFAJA EUDAMED
8X23GA003BCDNA EUDAMED
8X23OQ113BNDAA EUDAMED
8X24HF103BFBOA EUDAMED
8X23GE103BBABA EUDAMED
8X23GA003BFABA EUDAMED
8X23HR113FFAZA EUDAMED
8X23YY133FFDAB EUDAMED
8X23HQ103BFABA EUDAMED
8X23TN133BFAHB EUDAMED
8X23GF113DAAAA EUDAMED
8X23HR113BAACA EUDAMED
8X23GQ003DCAZA EUDAMED
8X23GN003BBBOA EUDAMED
8X23HC103DCAAA EUDAMED
8X23O3113BFDAA EUDAMED
8X23V5123DCADA EUDAMED
8X23OV133BCDSA EUDAMED
8X23SG113BFDSA EUDAMED
8X24HC003FBBOA EUDAMED
8X24HZ113DFAZA EUDAMED
8X23OG103DAABA EUDAMED
8X23GC103BFABA EUDAMED
8X23HQ133BFDSA EUDAMED
8X23GY113BFAZA EUDAMED
8X23HR113FADAA EUDAMED
8X24HR113DEDAA EUDAMED
8X23HR113DABOA EUDAMED
8X23GG103DEABA EUDAMED
8X23HG103DEABA EUDAMED
8X23TL133BBAHA EUDAMED
8X23GC003DBAAA EUDAMED
8X23GL103BBBOA EUDAMED
8X23GU103DEABA EUDAMED
8X23YH113FFAAA EUDAMED
8X23OQ113DEDAA EUDAMED
8X23HR113DFADA EUDAMED
8X23GM113BEDAA EUDAMED
8X23GQ103BCAHB EUDAMED
8X23GQ003BFABA EUDAMED
8X23GN003BCBOA EUDAMED
8X23GN003BEABB EUDAMED
8X24GA003BAABB EUDAMED
8X23GN103FCAHB EUDAMED
8X23TG113BBABA EUDAMED
8X23UG113BEABA EUDAMED
8X23G0103BDABA EUDAMED
8X23YB133FAACA EUDAMED
8X23Y0113DFADA EUDAMED
8X23RC013BCBOA EUDAMED
8X23GQ103BBAHB EUDAMED
8X23HY103BFABA EUDAMED
8X23HR133DEDSA EUDAMED
8X23HQ113BBADA EUDAMED
8X23HH103BBADA EUDAMED
8X23HQ113BDABA EUDAMED
8X23HB103BBAAA EUDAMED
8X23HQ113DCDAA EUDAMED
8X24OH113BDABA EUDAMED
8X23TL133BEAHB EUDAMED
8X23T1033BFAJA EUDAMED
8X23GL113BCAHB EUDAMED
8X23HR113BDACA EUDAMED
8X24OL113FEAHB EUDAMED
8X23V5103DCADA EUDAMED
8X23PL103DBABA EUDAMED
8X23SZ113FFDSA EUDAMED
8X23HR113FEDAA EUDAMED
8X23OR113DDDAA EUDAMED
8X23GE103DBAAA EUDAMED
8X23HQ113BEADA EUDAMED
8X23VQ133DFDSA EUDAMED
8X23UR113DFDAA EUDAMED
8X23GA003BBCHB EUDAMED
8X24OR113BFAHB EUDAMED
8X23GC003BBAZA EUDAMED
8X23HG003DEABA EUDAMED
8X23HY113BEAJA EUDAMED
8X24GG103DAAAA EUDAMED
8X23HD113BAAAA EUDAMED
8X23OQ103FDBOA EUDAMED
8X23GL113BEAHA EUDAMED
8X23HN103BCABA EUDAMED
8X23HL103FCBOA EUDAMED
8X23HZ113DBDAA EUDAMED
8X23UQ133BFABA EUDAMED
8X23HY113BEBOA EUDAMED
8X23HJ103DCDAA EUDAMED
8X23GA003BCAZA EUDAMED
8X23HZ113BDACA EUDAMED
8X33TQ113BFAHB EUDAMED
8X23GJ103BBAHB EUDAMED
8X23GS103BDABB EUDAMED
8X23GC003BBABA EUDAMED
8X23GC113BBAAB EUDAMED
8X23HR113BBACA EUDAMED
8X23PU103BFANA EUDAMED
8X23WZ113BCDAA EUDAMED
8X23GB103BBAAA EUDAMED
8X23HY133BFAJA EUDAMED
8X23GE113BABOA EUDAMED
8X23GU003BCAKB EUDAMED
8X23G0003DADAA EUDAMED
8X23HY113BCABA EUDAMED
8X23GL103BEAHB EUDAMED
8X23YY113BFANA EUDAMED
8X23GC003BCBOA EUDAMED
8X23HQ103DCABA EUDAMED
8X23HP103BEABB EUDAMED
8X23GM003BEAAB EUDAMED
8X23HP113BAACA EUDAMED
8X23HA003BCAZA EUDAMED
8X23HQ113BFAJA EUDAMED
8X23VG003BCAZA EUDAMED
8X23GS113BEABB EUDAMED
8X23GP103BEDJB EUDAMED
8X23GC103DDABA EUDAMED
8X24HJ103DCDAA EUDAMED
8X23HH103BDAAB EUDAMED
8X23HQ113BEACA EUDAMED
8X23HQ113FCDAA EUDAMED
8X23HU113FBBOA EUDAMED
8X23GG113DCAAA EUDAMED
8X23GG103BDABA EUDAMED
8X23HP113BDACA EUDAMED
8X23HG013DEABA EUDAMED
8X23HR113DCDAA EUDAMED
8X23GG013BDABA EUDAMED
8X23GC003BCAZA EUDAMED
8X23GR113BDDJB EUDAMED
8X23HZ113DADAA EUDAMED
8X23HR113BEACA EUDAMED
8X23HQ003DEABA EUDAMED
8X23GN103BDABA EUDAMED
8X23GL103BCAHA EUDAMED
8X23O2113BNDAA EUDAMED
8X23HL103BBAHB EUDAMED
8X23T5133BFDAA EUDAMED
8X23GE103BEABA EUDAMED
8X23GL003DEABA EUDAMED
8X23GD113BCAAA EUDAMED
8X23GL103BBAHA EUDAMED
8X23GL003FBBOA EUDAMED
8X23HQ103BBBOA EUDAMED
8X23GN103BCABA EUDAMED
8X23GS113DCDSA EUDAMED
8X24GL133DEBOA EUDAMED
8X23HR113DFDAA EUDAMED
8X23HQ113BBACA EUDAMED
8X23GQ003BABOA EUDAMED
8X23HZ113DEDAA EUDAMED
8X23VQ123BFAKB EUDAMED

Identifiers

Primary DI / UDI-DI
05055982758024 EUDAMED
05056097367170 EUDAMED
05055982752176 EUDAMED
05055982752442 EUDAMED
05056097330136 EUDAMED
05055982752626 EUDAMED
05056097300429 EUDAMED
05055982751971 EUDAMED
05055982752923 EUDAMED
05059441000020 EUDAMED
05055982751285 EUDAMED
05055982757973 EUDAMED
05055982752909 EUDAMED
05055982751568 EUDAMED
05055982752787 EUDAMED
05059441134220 EUDAMED
05059441130086 EUDAMED
05055982752794 EUDAMED
05056097360355 EUDAMED
05055982752527 EUDAMED
05056097344812 EUDAMED
05055982752930 EUDAMED
05055982751711 EUDAMED
05056097346274 EUDAMED
05055982753036 EUDAMED
05055982752503 EUDAMED
05059441131304 EUDAMED
05055982752831 EUDAMED
05056097328072 EUDAMED
05055982751582 EUDAMED
05055982752664 EUDAMED
05055982752671 EUDAMED
05056097318554 EUDAMED
05056097345642 EUDAMED
05055982752633 EUDAMED
05056097352817 EUDAMED
05059441128243 EUDAMED
05056097322735 EUDAMED
05059441149880 EUDAMED
05056341600695 EUDAMED
05055982751728 EUDAMED
05059441128540 EUDAMED
05056097304977 EUDAMED
05059441129707 EUDAMED
05056097304304 EUDAMED
05056097346328 EUDAMED
05056097356273 EUDAMED
05055982752718 EUDAMED
05055982752107 EUDAMED
05055982795685 EUDAMED
05055982752244 EUDAMED
05056097358093 EUDAMED
05059441145660 EUDAMED
05056097356259 EUDAMED
05056097351476 EUDAMED
05055982753081 EUDAMED
05056097304397 EUDAMED
05056097337449 EUDAMED
05055982751575 EUDAMED
05056097365954 EUDAMED
05055982752183 EUDAMED
05055982752879 EUDAMED
05055982753104 EUDAMED
05055982752770 EUDAMED
05055982785471 EUDAMED
05055982785563 EUDAMED
05056341675020 EUDAMED
05055982751421 EUDAMED
05059441147800 EUDAMED
05055982752152 EUDAMED
05056097335315 EUDAMED
05056097338866 EUDAMED
05055982785587 EUDAMED
05055982751995 EUDAMED
05059441145813 EUDAMED
05055982785549 EUDAMED
05056097370538 EUDAMED
05055982752015 EUDAMED
05059441100591 EUDAMED
05055982752084 EUDAMED
05059441147565 EUDAMED
05056097352732 EUDAMED
05056097360423 EUDAMED
05056097344454 EUDAMED
05059441134473 EUDAMED
05056097365435 EUDAMED
05056341600855 EUDAMED
05055982752947 EUDAMED
05056341699071 EUDAMED
05056097320304 EUDAMED
05055982752381 EUDAMED
05055982758086 EUDAMED
05056097319377 EUDAMED
05055982783996 EUDAMED
05056097327532 EUDAMED
05056341674962 EUDAMED
05056097332901 EUDAMED
05056097346311 EUDAMED
05055982752749 EUDAMED
05056097327167 EUDAMED
05059441020998 EUDAMED
05056341602576 EUDAMED
05056097329451 EUDAMED
05055982752916 EUDAMED
05059441148982 EUDAMED
05056097336992 EUDAMED
05055982758093 EUDAMED
05056097332734 EUDAMED
05059441148340 EUDAMED
05055982751254 EUDAMED
05056097321899 EUDAMED
05055982757843 EUDAMED
05056097356532 EUDAMED
05055982785600 EUDAMED
05055982753074 EUDAMED
05055982752268 EUDAMED
05059441132110 EUDAMED
05055982785518 EUDAMED
05056097300764 EUDAMED
05056341698357 EUDAMED
05055982752992 EUDAMED
05056097341095 EUDAMED
05055982758123 EUDAMED
05055982785570 EUDAMED
05056097331355 EUDAMED
05055982752978 EUDAMED
05059441129042 EUDAMED
05055982751902 EUDAMED
05056097333526 EUDAMED
05059441126034 EUDAMED
05059441021575 EUDAMED
05055982752725 EUDAMED
05056097338330 EUDAMED
05056097367187 EUDAMED
05055982751407 EUDAMED
05056097366364 EUDAMED
05055982751797 EUDAMED
05056097349183 EUDAMED
05059441129677 EUDAMED
05056097304106 EUDAMED
05055982785501 EUDAMED
05056097350905 EUDAMED
05056097316505 EUDAMED
05055982752619 EUDAMED
05055982752534 EUDAMED
05055982751988 EUDAMED
05055982752558 EUDAMED
05055982752213 EUDAMED
05055982758109 EUDAMED
05056097364377 EUDAMED
05056097346182 EUDAMED
05055982785532 EUDAMED
05056097346335 EUDAMED
05055982785617 EUDAMED
05055982752398 EUDAMED
05055982752657 EUDAMED
05055982752695 EUDAMED
05056097334301 EUDAMED
05055982751858 EUDAMED
05056097356266 EUDAMED
05055982752565 EUDAMED
05055982752336 EUDAMED
05055982752817 EUDAMED
05059441147404 EUDAMED
05055982757850 EUDAMED
05056097350820 EUDAMED
05055982752985 EUDAMED
05055982752756 EUDAMED
05056341602033 EUDAMED
05055982752053 EUDAMED
05059441129967 EUDAMED
05059441137436 EUDAMED
05059441100515 EUDAMED
05056097352787 EUDAMED
05055982757935 EUDAMED
05055982785495 EUDAMED
05055982751681 EUDAMED
05059441141693 EUDAMED
05056097369006 EUDAMED
05055982752602 EUDAMED
05055982752046 EUDAMED
05056097352022 EUDAMED
05059441021780 EUDAMED
05055982751209 EUDAMED
05055982752855 EUDAMED
05055982758079 EUDAMED
05059441128342 EUDAMED
05055982753029 EUDAMED
05056097350813 EUDAMED
Basic UDI-DI
5060693520143VW EUDAMED
EMDN Code
V08060103 SEMI-INTENSIVE THERAPY OR CARDIAC INTENSIVE CARE UNITS (CICU) ELECTRIC MEDICAL BEDS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED
Germany EUDAMED
Italy EUDAMED
Poland EUDAMED
Ireland EUDAMED
Romania EUDAMED
Netherlands EUDAMED
Austria EUDAMED
Hungary EUDAMED
Belgium EUDAMED
Bulgaria EUDAMED
Spain EUDAMED
Czechia EUDAMED
Greece EUDAMED
Norway EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Enterprise 8000x by Arjohuntleigh AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (190)

  • EUDAMED 2cff8e07-ca45-4d22-a600-207a7d835968 61 fields · synced Sep 30, 2026
  • EUDAMED 37560719-6aa2-4f23-96a0-269cf8320d3b 61 fields · synced May 11, 2026
  • EUDAMED 86f85fc7-901e-4fa3-aa30-6b6c492c48de 61 fields · synced May 11, 2026
  • EUDAMED b80e5af1-723f-4824-934c-8e4e317a4910 61 fields · synced May 11, 2026
  • EUDAMED 1224cea3-9a73-4134-9adf-d5081f48ee07 61 fields · synced May 11, 2026
  • EUDAMED 139b6ae4-5ba2-4e27-9c97-fda13df450cc 61 fields · synced May 11, 2026
  • EUDAMED 1a8b8d60-28f5-46c8-9df4-8a9366baf2ec 61 fields · synced May 11, 2026
  • EUDAMED 16822254-53b2-43eb-805e-f8576252f3f2 61 fields · synced May 11, 2026
  • EUDAMED a1101d58-80e4-4d93-b9af-95349e76a704 61 fields · synced May 16, 2026
  • EUDAMED 4cc1c1d6-10ca-47b5-ac79-6a7477a9dc69 61 fields · synced May 16, 2026
  • EUDAMED 28d6e904-e480-4362-95bd-eff25bdda9eb 61 fields · synced May 16, 2026
  • EUDAMED 9b7464b6-4025-4f13-9a17-4c4ee24edd15 61 fields · synced May 16, 2026
  • EUDAMED a5abf780-4695-41c9-a32b-732da1ff609f 61 fields · synced May 16, 2026
  • EUDAMED 5eb1506d-5be1-40e8-9d5b-6ddc0bfaa370 61 fields · synced May 16, 2026
  • EUDAMED f6adc5e6-a715-45d3-8c55-f08af21ac716 61 fields · synced May 16, 2026
  • EUDAMED 82e5528d-d1a9-44cd-94b1-db9c40a7715a 61 fields · synced May 16, 2026
  • EUDAMED f664cd35-16a5-46c2-9e61-d57e24c4b625 61 fields · synced May 16, 2026
  • EUDAMED 78a3d0cb-9c9b-4f62-8234-ed5c443af966 61 fields · synced May 16, 2026
  • EUDAMED 6787d015-10b8-4ba6-8649-9c5a5449ef9b 61 fields · synced May 16, 2026
  • EUDAMED 3bd2c5d2-a4ae-496b-a298-ff26880cdf26 61 fields · synced May 16, 2026
  • EUDAMED 380d48a9-21a5-432f-bbf5-17143233e569 61 fields · synced May 16, 2026
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